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Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT

NCT05831098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-01-26

No results posted yet for this study

Summary

This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).

Conditions

  • Syphilis Infection
  • Syphilis
  • Early Syphilis, Symptomatic

Interventions

DEVICE

Reveal TP (Syphilis) Antibody Test

All subjects tested with both investigational devices and conventional syphilis serology tests.

Sponsors & Collaborators

  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV

  • MedMira Laboratories Inc.

    lead INDUSTRY

Principal Investigators

  • Troy Grennan, Dr · British Columbia Center for Disease Control (BCCDC)

  • Raymond Tsang, Dr · National Microbiology Laboratory Branch, Public Health Agency of Canada

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831098 on ClinicalTrials.gov